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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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Primary Objective: use immunofluorescence (IF) on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-L-lactic acid (PLLA) or saline.
Sixteen female adults that participated in SPLASH study will be enrolled in this retrospective study. It aims to analyze previously collected biopsy samples from participants who completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" study. The study will use immunohistology to assess changes in adipose tissue associated with treatment with PLLA (poly-L-lactic acid). We hypothesize that specimens treated with PLLA will be found to have more adipocyte-derived stem cells and preadipocytes undergoing mitosis and differentiation compared to control specimens.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsies | Diagnostic Test | Analyze previous biopsies to quantify changes induced by Poly-L-Lactic Acid in Adipose Tissue |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cell count per area between PLLA and saline-treated specimens. | Analyzing between PLLA and saline-treated specimens for the following populations:
| Specimens are from 6 months post-treatment compared to pre-treatment / Baseline |
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Inclusion Criteria:
Exclusion Criteria:
Previous study was only done on females due to skin quality and aesthetic concerns
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16 Females that were previously enrolled and biopsied in SPLASH study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cosmetic Laser Dermatology/West Dermatology Research Center | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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